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Recruiting

A Study to Assess DF6002 (BMS-986415) Alone and in Combination With Nivolumab in Participants With Locally Advanced or Metastatic Solid Tumors - CA101-001

Updated: 28 June, 2022   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
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Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1/Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 9

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Combination Dose Escalation
Drug: Nivolumab Drug: DF6002
Experimental: Combination Dose Expansion (Melanoma)
Drug: Nivolumab Drug: DF6002
Experimental: Combination Dose Expansion (NSCLC)
Drug: Nivolumab Drug: DF6002
Experimental: Monotherapy Dose Escalation
Drug: DF6002
Experimental: Monotherapy Dose Expansion (Melanoma)
Drug: DF6002
Experimental: Monotherapy Dose Expansion (NSCLC)
Drug: DF6002

Key Eligibility Criteria

Inclusion Criteria: - Advanced/metastatic solid tumors, for which no standard therapy exists or standard therapy has failed among the following tumor types: melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell, urothelial, gastric, esophageal, cervical, hepatocellular, merkel cell, cutaneous squamous cell carcinoma, renal cell, endometrial, triple-negative breast, ovarian, and prostate - ECOG performance status of 0 or 1 - Clinical or radiological evidence of disease - Adequate hematological, hepatic and renal function - Anticoagulants are required for the following: Khorana Risk Score ≥ 2 or as assessed by Investigator as being at high risk for venous thromboembolism (VTE) or history of VTE ≥ 6 months from enrollment Exclusion Criteria: - Concurrent anticancer treatment (with the exception of palliative bone directed radiotherapy), immune therapy, or cytokine therapy (except for erythropoietin), major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days before the start of study treatment - Previous malignant disease other than the current target malignancy within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin, localized prostate cancer or cervical carcinoma in situ - Rapidly progressive disease - Serious cardiac illness or medical conditions - Known diagnosis of antiphospholipid syndrome or clinically significant hereditary thrombophilia Other protocol-defined inclusion/exclusion criteria apply

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Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com